Interpretation of updated 2021 CSCO guidelines for the diagnosis and treatment of metastatic gastric cancer
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摘要: 对于晚期或转移性胃癌患者，目前公认采取以全身抗肿瘤药物治疗为主的多学科综合治疗和全程多方位管理以延长患者生存时间和改善患者生存质量。中国临床肿瘤学会（CSCO）胃癌诊疗指南每年更新，融合国内外最新的临床研究进展，关注中国人群研究数据和贴近本国临床实践。2021版CSCO转移性胃癌诊疗指南更新主要围绕免疫治疗、抗HER2靶向治疗和胃癌支持治疗等方面展开。基于2020年晚期胃癌在免疫治疗取得重大突破，更新重点聚焦免疫治疗，2021版CSCO指南从新的临床证据出发，针对免疫治疗从一线到三线，如何选择不同的程序性死亡受体-1（programmed cell death 1，PD-1）单抗药物，不同的适用人群均作出了详细推荐及注释，以期规范免疫治疗在晚期胃癌中的应用。本文就2021版CSCO指南对免疫治疗、抗HER2靶向治疗和胃癌支持治疗等方面的更新作总结性的解读，概括性阐明2021版CSCO中反映的晚期转移性胃癌治疗的新进展。Abstract: Multidisciplinary comprehensive treatment and whole-process multi-directional management based on systemic antitumor drugs are generally adopted in patients with advanced or metastatic gastric cancer in order to prolong survival and improve the quality of life of patients. The Chinese Society of Clinical Oncology (CSCO) guidelines for the diagnosis and treatment of gastric cancer are updated every year. The guidelines integrate the latest advances in domestic and foreign clinical research and serve to guide domestic clinical practice. The updated 2021 CSCO Guidelines for the Diagnosis and Treatment of Metastatic Gastric Cancer mainly focused on immunotherapy, anti-human epidermal growth factor receptor 2 (anti-HER2)-targeted therapy, and supportive therapy. The updated guidelines focus on the major developments in immunotherapy for advanced gastric cancer in 2020. Detailed recommendations and notes were made on the clinical application of immunotherapy (from first-line to third-line treatment), choices of different programmed death 1 (PD-1) antibodies, and different applicable populations, so as to standardize the application of immunotherapy in advanced gastric cancer. This article summarizes the updates on immunotherapy, anti-HER2-targeted therapy, and supportive care for gastric cancer in the new CSCO guidelines, in order to generalize the new progress in the treatment of advanced metastatic gastric cancer reflected in the new CSCO guidelines.
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Key words:
- metastatic gastric cancer /
- CSCO guidelines /
- immunotherapy /
- targeted therapy
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表 1 晚期胃癌免疫治疗主要临床试验
临床试验注册名称 研究阶段 治疗线数 人群PD-L1特点 治疗药物 中位总生存期（月） 中位无进展生存期（月） KEYNOTE-062[3] Ⅲ期 一线 CPS≥10分 帕博利珠单抗（n=92） 17.40 2.90 帕博利珠单抗+化疗 （n=99） 12.30 − 化疗（n=90） 10.80 6.10 CPS≥1分 帕博利珠单抗（n=256） 10.60 2.00 帕博利珠单抗+化疗 （n=257） 12.50 6.90 化疗（n=250） 11.10 6.40 CheckMate-649[4] Ⅲ期 一线 CPS≥5分 纳武利尤单抗联合化疗 （n=473） 14.40 7.70 单纯化疗（n=482） 11.10 6.00 全人群 纳武利尤单抗联合化疗 （n=789） 13.80 7.70 单纯化疗（n=792） 11.60 6.90 ATTRACTION-4[5] Ⅱ/Ⅲ期 一线 − 纳武利尤单抗联合化疗 （n=473） 17.45 10.45 单纯化疗（n=482） 17.15 8.34 KEYNOTE-059队列3[7] Ⅱ期 − CPS≥1分 帕博利珠单抗 20.70 3.30 KEYNOTE-061[9] Ⅲ期 二线 CPS ≥1分 帕博利珠单抗（n=196） 9.10 1.50 紫杉醇单药（n=199） 8.30 4.20 ORIENT-16（大会报道） Ⅲ期 一线 CPS≥5分 信迪利单抗联合化疗 （n=197） 18.40 7.70 单纯化疗（n=200） 12.90 5.80 全人群 信迪利单抗联合化疗 （n=327） 15.20 7.10 单纯化疗（n=323） 12.30 5.70 
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表 2 HER2阳性胃癌主要临床试验
临床试验注册名称 研究阶段 治疗线数 治疗药物 中位总生存期（月） 中位无进展生存期（月） ToGA[14] Ⅲ期 一线 赫赛汀+化疗（n=294） 13.80 6.70 单纯化疗（n=290） 11.10 5.50 JACOB[15] Ⅲ期 一线 帕妥珠单抗+曲妥珠单抗+化疗（n=388） 17.50 8.50 曲妥珠单抗+化疗（n=392） 14.20 7.00 TRIO-013/LOGiC[16] Ⅲ期 一线 拉帕替尼+曲妥珠单抗+化疗（n=272） 12.20 6.00 曲妥珠单抗+化疗（n=273） 10.50 5.40 TyTAN[17] Ⅲ期 二线 拉帕替尼+化疗（n=132） 11.00 5.50 单纯化疗（n=129） 8.90 4.40 GATSBY[18] Ⅱ/Ⅲ期 一线 T-DM1 单药（n=228） 7.90 2.90 化疗（n=117） 8.60 2.70 DESTINY-gastric01[19] Ⅲ期 三线 DS-8201单药（n=125） 12.50 − 单纯化疗（n=62） 8.40 − RC48-C008[20] Ⅱ期 三线 维迪西妥单抗（n=127） 7.60 4.10
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[1] Global Burden of Disease Cancer Collaboration, Fitzmaurice C, Allen C, et al. Global, regional, and national cancer incidence, mortality, years of life lost, years lived with disability, and disability-adjusted life-years for 32 cancer groups, 1990 to 2015: A systematic analysis for the global burden of disease study[J]. JAMA Oncol, 2017, 3(4):524-548. doi: 10.1001/jamaoncol.2016.5688 [2] Tang LL, Chen YP, Chen CB, et al. The Chinese Society of Clinical Oncology (CSCO) clinical guidelines for the diagnosis and treatment of nasopharyngeal carcinoma[J]. Cancer Commun (Lond), 2021, 41(11):1195-1227. doi: 10.1002/cac2.12218 [3] Shitara K, Van Cutsem E, Bang YJ, et al. Efficacy and safety of pembrolizumab or pembrolizumab plus chemotherapy vs chemotherapy alone for patients with first-line, advanced gastric cancer: The KEYNOTE-062 phase 3 randomized clinical trial[J]. JAMA Oncol, 2020, 6(10):1571-1580. doi: 10.1001/jamaoncol.2020.3370 [4] Janjigian YY, Shitara K, Moehler M, et al. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): a randomised, open-label, phase 3 trial[J]. Lancet, 2021, 398(10294):27-40. doi: 10.1016/S0140-6736(21)00797-2 [5] Boku N, Ryu MH, Kato K, et al. Safety and efficacy of nivolumab in combination with S-1/capecitabine plus oxaliplatin in patients with previously untreated, unresectable, advanced, or recurrent gastric/gastroesophageal junction cancer: interim results of a randomized, phase II trial (ATTRACTION-4) [J]. Ann Oncol, 2019, 30(2):250-258. [6] Ajani JA, D'amico TA, Bentrem DJ, et al. Gastric cancer, version 2.2022, NCCN clinical practice guidelines in oncology[J]. J Natl Compr Canc Netw, 2022, 20(2):167-192. [7] Fuchs CS, Doi T, Jang RW, et al. Safety and efficacy of pembrolizumab monotherapy in patients with previously treated advanced gastric and gastroesophageal junction cancer: phase 2 clinical KEYNOTE-059 trial[J]. JAMA Oncol, 2018, 4(5):e180013. doi: 10.1001/jamaoncol.2018.0013 [8] Shitara K, Ozguroglu M, Bang YJ, et al. Pembrolizumab versus paclitaxel for previously treated, advanced gastric or gastro-oesophageal junction cancer (KEYNOTE-061): a randomised, open-label, controlled, phase 3 trial[J]. Lancet, 2018, 392(10142):123-133. doi: 10.1016/S0140-6736(18)31257-1 [9] Le DT, Durham JN, Smith KN, et al. Mismatch repair deficiency predicts response of solid tumors to PD-1 blockade[J]. Science, 2017, 357(6349):409-413. doi: 10.1126/science.aan6733 [10] Chao J, Fuchs CS, Shitara K, et al. Assessment of pembrolizumab therapy for the treatment of microsatellite instability-high gastric or gastroesophageal junction cancer among patients in the KEYNOTE-059, KEYNOTE-061, and KEYNOTE-062 clinical trials[J]. JAMA Oncol, 2021, 7(6):895-902. doi: 10.1001/jamaoncol.2021.0275 [11] Andre T, Shiu KK, Kim TW, et al. Pembrolizumab in microsatellite-instability-high advanced colorectal cancer[J]. N Engl J Med, 2020, 383(23):2207-2218. doi: 10.1056/NEJMoa2017699 [12] Pietrantonio F, Miceli R, Raimondi A, et al. Individual patient data meta-analysis of the value of microsatellite instability as a biomarker in gastric cancer[J]. J Clin Oncol, 2019, 37(35):3392-3400. doi: 10.1200/JCO.19.01124 [13] Kim JW, Cho SY, Chae J, et al. Adjuvant chemotherapy in microsatellite instability-high gastric cancer[J]. Cancer Res Treat, 2020, 52(4):1178-1187. [14] Bang YJ, Van Cutsem E, Feyereislova A, et al. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial[J]. Lancet, 2010, 376(9742):687-697. doi: 10.1016/S0140-6736(10)61121-X [15] Tabernero J, Hoff PM, Shen L, et al. Pertuzumab plus trastuzumab and chemotherapy for HER2-positive metastatic gastric or gastro-oesophageal junction cancer (JACOB): final analysis of a double-blind, randomised, placebo-controlled phase 3 study[J]. Lancet Oncol, 2018, 19(10):1372-1384. doi: 10.1016/S1470-2045(18)30481-9 [16] Hecht JR, Bang YJ, Qin SK, et al. Lapatinib in combination with capecitabine plus oxaliplatin in human epidermal growth factor receptor 2-positive advanced or metastatic gastric, esophageal, or gastroesophageal adenocarcinoma: TRIO-013/LOGiC-A randomized phase Ⅲ trial[J]. J Clin Oncol, 2016, 34(5):443-451. doi: 10.1200/JCO.2015.62.6598 [17] Satoh T, Xu RH, Chung HC, et al. Lapatinib plus paclitaxel versus paclitaxel alone in the second-line treatment of HER2-amplified advanced gastric cancer in Asian populations: TyTAN—a randomized, phase III study[J]. J Clin Oncol, 2014, 32(19):2039-2049. doi: 10.1200/JCO.2013.53.6136 [18] Wagner AD, Syn NL, Moehler M, et al. Chemotherapy for advanced gastric cancer [J]. Cochrane Database Syst Rev, 2017, 8(8):CD004064. [19] Shitara K, Bang YJ, Iwasa S, et al. Trastuzumab deruxtecan in previously treated HER2-positive gastric cancer[J]. N Engl J Med, 2020, 382(25):2419-2430. doi: 10.1056/NEJMoa2004413 [20] Xu Y, Wang Y, Gong J, et al. Phase I study of the recombinant humanized anti-HER2 monoclonal antibody–MMAE conjugate RC48-ADC in patients with HER2-positive advanced solid tumors[J]. Gastric Cancer, 2021, 24(4):913-925. doi: 10.1007/s10120-021-01168-7 [21] Guo ZQ, Yu JM, Li W, et al. Survey and analysis of the nutritional status in hospitalized patients with malignant gastric tumors and its influence on the quality of life[J]. Support Care Cancer, 2020, 28(1):373-380. doi: 10.1007/s00520-019-04803-3 [22] Lu Z, Fang Y, Liu C, et al. Early interdisciplinary supportive care in patients with previously untreated metastatic esophagogastric cancer: A phase Ⅲ randomized controlled trial[J]. J Clin Oncol, 2021, 39(7):748-756. doi: 10.1200/JCO.20.01254 [23] Kim YI, Choi IJ. Endoscopic management of tumor bleeding from inoperable gastric cancer[J]. Clin Endosc, 2015, 48(2):121-127. doi: 10.5946/ce.2015.48.2.121 [24] Iqbal U, Khara HS, Hu Y, et al. EUS-guided gastroenterostomy for the management of gastric outlet obstruction: A systematic review and meta-analysis[J]. Endosc Ultrasound, 2020, 9(1):16-23. doi: 10.4103/eus.eus_70_19 -
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